Daily. Med - DURAGESIC- fentanyl patch. Addiction, Abuse, and Misuse DURAGESIC contains fentanyl, an opioid agonist and a Schedule II controlled substance. As an opioid, DURAGESIC exposes users to the risks of addiction, abuse, and misuse . As modified- release products such as DURAGESIC deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of fentanyl present. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed DURAGESIC and in those who obtain the drug illicitly. Addiction can occur at recommended doses and if the drug is misused or abused. Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing DURAGESIC, and monitor all patients receiving DURAGESIC for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol addiction or abuse) or mental illness (e. The potential for these risks should not, however, prevent the prescribing of DURAGESIC for the proper management of pain in any given patient. Patients at increased risk may be prescribed modified- release opioid formulations such as DURAGESIC, but use in such patients necessitates intensive counseling about the risks and proper use of DURAGESIC along with intensive monitoring for signs of addiction, abuse, and misuse. Abuse or misuse of DURAGESIC by placing it in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose, and death . Consider these risks when prescribing or dispensing DURAGESIC. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug . Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Life- Threatening Respiratory Depression. Serious, life- threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression from opioid use, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status . Carbon dioxide (CO2) retention from opioid- induced respiratory depression can exacerbate the sedating effects of opioids. DURAGESIC is indicated only in opioid tolerant patients because of the risk for respiratory depression and death. While serious, life- threatening, or fatal respiratory depression can occur at any time during the use of DURAGESIC, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression when initiating therapy with DURAGESIC. To reduce the risk of respiratory depression, proper dosing and titration of DURAGESIC are essential . Overestimating the DURAGESIC dose when converting patients from another opioid product can result in fatal overdose with the first dose. Accidental exposure to DURAGESIC, especially in children, can result in respiratory depression and death due to an overdose of fentanyl. Accidental Exposure. A considerable amount of active fentanyl remains in DURAGESIC even after use as directed. Death and other serious medical problems have occurred when children and adults were accidentally exposed to DURAGESIC. Accidental or deliberate application or ingestion by a child or adolescent will cause respiratory depression that can result in death. Placing DURAGESIC in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking or overdose that could result in death. Improper disposal of DURAGESIC in the trash has resulted in accidental exposures and deaths. Learn about the potential side effects of Duragesic-25 (fentanyl). Includes common and rare side. Common side effects of Duragesic-25. 25 mcg m,w,f since Jan 23, 2013. The fentanyl transdermal patch may burn your skin if you wear. Discontinue all other around-the-clock opioid drugs when initiating the fentanyl patch.Fentanyl side effects and concerns. 87.5 mcg/hour, 12 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr. I have been on the fentanyl patch for 18 yrs now. Advise patients about strict adherence to the recommended handling and disposal instructions in order to prevent accidental exposure to DURAGESIC . Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life- threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Interactions with Central Nervous System Depressants Hypotension, profound sedation, coma, respiratory depression, and death may result if DURAGESIC is used concomitantly with alcohol or other central nervous system (CNS) depressants (e. When considering the use of DURAGESIC in a patient taking a CNS depressant, assess the duration use of the CNS depressant and the patient's response, including the degree of tolerance that has developed to CNS depression. Additionally, evaluate the patient's use of alcohol or illicit drugs that cause CNS depression. If the decision to begin DURAGESIC is made, reduce the starting dose, monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant . Monitor such patients closely, particularly when initiating and titrating DURAGESIC and when DURAGESIC is given concomitantly with other drugs that depress respiration . Consider the use of alternative non- opioid analgesics in these patients if possible. Head Injuries and Increased Intracranial Pressure. Avoid use of DURAGESIC in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure, impaired consciousness, or coma . In addition, opioids may obscure the clinical course of patients with head injury. Monitor patients with brain tumors who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression, particularly when initiating therapy with DURAGESIC, as DURAGESIC may reduce respiratory drive and CO2 retention can further increase intracranial pressure. Hypotensive Effects. DURAGESIC may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e. Monitor these patients for signs of hypotension after initiating or titrating the dose of DURAGESIC. Interactions with CYP3. A4 Inhibitors and Inducers Since the CYP3. A4 isoenzyme plays a major role in the metabolism of DURAGESIC, drugs that alter CYP3. A4 activity may cause changes in clearance of fentanyl which could lead to changes in fentanyl plasma concentrations. The concomitant use of DURAGESIC with a CYP3. A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil) may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Carefully monitor patients receiving DURAGESIC and any CYP3. A4 inhibitor for signs of sedation and respiratory depression for an extended period of time, and make dosage adjustments as needed. CYP4. 50 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of fentanyl and, therefore, may cause increased clearance of the drug which could lead to a decrease in fentanyl plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome in a patient who had developed physical dependence to fentanyl. If co- administration is necessary, caution is advised when initiating DURAGESIC treatment in patients currently taking, or discontinuing, CYP3. A4 inhibitors or inducers. Evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved . A clinical pharmacology study conducted in healthy adult subjects has shown that the application of heat over the DURAGESIC system increased fentanyl exposure . Monitor patients wearing DURAGESIC systems who develop fever closely for opioid side effects and reduce the DURAGESIC dose if necessary. Warn patients to avoid strenuous exertion that leads to increased core body temperature while wearing DURAGESIC to avoid the risk of potential overdose and death. Cardiac Disease. DURAGESIC may produce bradycardia. Monitor patients with bradyarrhythmias closely for changes in heart rate, particularly when initiating therapy with DURAGESIC. Hepatic Impairment. A clinical pharmacology study with DURAGESIC in patients with cirrhosis has shown that systemic fentanyl exposure increased in these patients. Because of the long half- life of fentanyl when administered as DURAGESIC and hepatic metabolism of fentanyl, avoid use of DURAGESIC in patients with severe hepatic impairment. Insufficient information exists to make precise dosing recommendations regarding the use of DURAGESIC in patients with impaired hepatic function. Therefore, to avoid starting patients with mild to moderate hepatic impairment on too high of a dose, start with one half of the usual dosage of DURAGESIC. Durogesic DTrans 12 mcg/hr Transdermal Patch. Accidental transfer of a fentanyl patch. The risk of fentanyl patch's side effects, including breathing problems. Store fentanyl patch below 77 degrees F (25 degrees C) in its original sealed pouch. Does anyone have any experience with 25 mcg Fentanyl patches Side effects? Duragesic-25 (fentanyl transdermal patch). Fentanyl can cause side effects that may impair. Closely monitor for signs of sedation and respiratory depression, including at each dosage increase. Fentanyl (Transdermal Route) Side Effects. Drug information provided by: Micromedex. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: More common. Decrease in the amount of urine or in the frequency of urination. Incidence not known. Bloating or swelling of the face, hands, lower legs, or feet. Get emergency help immediately if any of the following symptoms of overdose occur: Symptoms of overdose. Cold, clammy skin. Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common. Abdominal or stomach pain that was not present before treatment. Feeling anxious and restless at the same time. Incidence not known. Change or problem with discharge of semen. After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects: Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1- 8. FDA- 1. 08. 8. Portions of this document last updated: Jan. 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